RX only stryker User manual

User Guide
SIDNE®Berchtold
ChromoVision®
Overhead Camera
REF 240-020-839

EN-1
SIDNE®Berchtold®
ChromoVision®
Overhead Camera
User Guide
Contents
Warnings and Cautions .....................................EN-2
Product Description ..........................................EN-4
Intended Use ...............................................................................EN-4
Package Contents ...................................................................... EN-4
Setup and Interconnection ...............................EN-5
Quick Startup Guide ...................................................................EN-5
Connecting SIDNE to the Berchtold ChromoVision Camera ...... EN-5
Mounting the EDAM .................................................................... EN-7
Installing the Berchtold ChromoVision Camera Driver Upgrade EN-7
System Operation .............................................EN-9
SIDNE Feedback Messages .....................................................EN-11
Notes on Operation ...................................................................EN-11
Troubleshooting ............................................. EN-13
Electromagnetic Compatibility ........................ EN-14

EN-2
Warnings and Cautions
Please read this manual and follow its instructions carefully. The words warning,
caution, and note carry special meanings and should be carefully reviewed:
Warning The personal safety of the patient or physician may be
involved. Disregarding this information could result in injury
to the patient or user.
Caution Special service procedures or precautions must be followed to
avoid damaging the instrument.
Note Special information to make maintenance easier or important
information more clear.
An exclamation mark within a triangle is intended to alert the
user to the presence of important operating and maintenance
instructions in the literature accompanying the product.
A lightning bolt within a triangle is intended to warn of the
presence of hazardous voltage. Refer all service to authorized
personnel.
Warning To avoid potential serious injury or electric shock to the
patient and/or operating personnel, please note the following
warnings:
1. To avoid potential serious injury to the user and patient and/or damage
to this device, read the Berchtold® ChromoVision® Overhead Camera
(hereafter the Berchtold Camera) operating manual thoroughly and be
familiar with its contents prior to using this equipment.
2. The Berchtold Camera is designed to be used by a qualified physician
familiar with its use. Misusing the Berchtold Camera may cause injury to
the patient and/or damage system components.
3. To prevent injury, carefully unpack the kit and check if any damage
occurred during shipment. If damage is detected, DO NOT use the
equipment.
4. To prevent injury or electrical shock to the patient and/or operating
room personnel, always power off the Berchtold Camera when
connecting or disconnecting accessories.
5. Do not immerse the Berchtold Camera EDAM or allow fluid to enter the
chassis or connector as this will damage the equipment.

EN-3
6. Before and after each use, inspect the cord insulation for cracks, nicks,
cuts, dents, or depressions. Any irregularity will decrease the insulation
effectiveness and may result in shocks to the patient and/or operating
room personnel.
7. Ensure that the SIDNE® Berchtold® ChromoVision Overhead Camera
EDAM (hereafter referred to as "EDAM") is securely mounted to the
Berchtold Camera control box or cart as damage may occur.

EN-4
Product Description/Intended Use
The SIDNE® Berchtold® ChromoVision Camera system is a hardware/software
interface between the SIDNE® voice-activation system and the Berchtold®
ChromoVision Camera system. This enables the physician to have voice-activated
or touch-screen control of the Berchtold® Camera system.
The SIDNE® Berchtold® Camera Driver 1.0 upgrade allows the SIDNE® console
to communicate with the Berchtold® Camera.
Indications/Contraindications
The SIDNE® Berchtold® Camera or Light drivers are intended for use in voice
activation and control of attached voice compatible devices. It is indicated for use
in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic
surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. The
users of such a device are general surgeons, gynecologists, cardiac surgeons,
thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and
urologists.
There are no known contraindications.
Package Contents
The Berchtold® Camera includes the following components:
1. Device adapter cable
2. SIDNE® Berchtold® ChromoVision Camera EDAM
3. SIDNE® interface cable
4. Velcro strips for mounting the EDAM
5. SIDNE® Berchtold® ChromoVision Camera Driver 1.0 - USB dongle
4
13
2
5

EN-5
Setup and Interconnection
Quick Startup Guide
This section outlines the startup instructions for experienced users. Refer to the
relevant section(s) of this manual for further details.
1. Power off the Berchtold® Camera and SIDNE®.
2. Connect the Berchtold Camera to SIDNE.
• Connect the device adapter cable to the Berchtold ChromoVision®
Camera.
• Connect the device adapter cable to the EDAM.
• Connect the SIDNE interface cable to the EDAM.
• Connect the SIDNE interface cable to SIDNE.
•MounttheEDAM.
3. Power on the SIDNE console.
4. Install the Berchtold ChromoVision Camera Driver 1.0 upgrade. SIDNE
will restart.
5. Wait for SIDNE to say “SIDNE ready” before powering on the Berchtold
Camera.
Caution SIDNE should say “Overhead Camera Connected” and the
EDAM LED should flash green within 20 seconds of powering
on the Berchtold Camera. A different LED output may indicate
device problems. If the LED does not flash green
after 20 seconds, refer to the “Troubleshooting” section of this
manual for instructions.
6. Power on the Berchtold Camera. This completes the installation
procedure.
Connecting SIDNE to the Berchtold ChromoVision
Camera
1. Power off the Camera and the SIDNE® console.

EN-6
2. Connect the device adapter cable to the serial port of the Berchtold®
ChromoVision Camera (see below).
3. Connect the female end of the of the device adapter cable to the nine-pin
connector on the EDAM (see below).
4. Connect the SIDNE® interface cable to the USB connector on the EDAM
(see below).
5. Connect the other end of the SIDNE interface cable to one of the eight
USB ports on the SIDNE console (see below).
The SIDNE console is now connected to the Berchtold® ChromoVision Camera.

EN-7
Mounting the EDAM
Stryker recommends securing the EDAM in a secure location on a cart.
1. Remove the velcro strips from the kit.
2. Carefully peel the protective paper backing covering the adhesive side of
the velcro strips.
3. Attach one velcro strip to the underside (side without label) of the
EDAM and the other velcro strip to the desired location.
4. Securely mount the EDAM in the desired location using the velcro strips
(see below).
Installing the Berchtold ChromoVision Camera
Driver Upgrade
Note Read the “Notes on Operation” section at the end of this
procedure before using the SIDNE® console to control the
Berchtold® Camera.
Note Do not attempt to install any other software driver until the
installation of the Berchtold Camera Driver is complete and the
SIDNE console has restarted.
1. Power on the SIDNE console and wait until SIDNE says “SIDNE ready.”
2. Insert the dongle into the device-driver dongle port on the front SIDNE
panel (see below).

EN-8
Note After installation, the driver dongle will work only with the
system to which it has been installed. It can be reinstalled on that
system, but it will not work with other systems.
Caution To avoid equipment damage, please do not remove the dongle
card before SIDNE® says, “Please remove card.”
3. Follow the voice instructions given by SIDNE.
4. Wait as SIDNE restarts. When the console says, “SIDNE ready,” the
driver is installed and ready for use.
Caution SIDNE should say “Overhead Camera Connected” and the
EDAM LED should flash green within 20 seconds of powering
on the Berchtold® ChromoVision Camera. A different LED
output may indicate device problems. If the LED does not flash
green after 20 seconds, refer to the “Troubleshooting” section
of this manual for instructions.
When SIDNE says this... Do this...
“Software card detected. Please stand by.” Wait for the next instruction.
“Programming failed.”
(SIDNE will announce this message only
if the programming failed.)
Remove and reinsert the dongle.
“Programming complete.” Wait for the next instruction.
“Please remove card.” Remove the driver dongle from the
SIDNE console.

EN-9
System Operation
The tablet touchscreen commands for the Berchtold® ChromoVision Camera are
displayed in the image below and described in the following table. For more
information on how to operate the SIDNE® Tablet, refer to the SIDNE Operating
and Maintenance Manual (P/N 1000400988).
The Voice commands for controlling the Berchtold ChromoVision Camera
are displayed in the figure below and described in the following table. For
more information on how to operate the SIDNE Voice interface, refer to the
SIDNE Operating and Maintenance Manual (P/N 1000400988).
Top
Level
Device
Selection Control Selection Description
SIDNE° Ovrhd
Camera
Shutter Automatic Set shutter to automatic control
brightness
Manual Turn off automatic control of brightness
Brighter Increase light level
Darker Decrease light level
Focus Automatic Set Camera to automatic focus mode
Manual Turn off automatic focus mode
Out Focus Camera out
In Focus Camera in
Rotate Right Rotate camera continuously to the right
Left Rotate camera continuously to the left
Zoom In Zoom in continuously
Zoom Out Zoom out continuously
White Balance Initiate White Balance

EN-10
Top
Level
Device
Selection Control Selection Description
SIDNE® Ovrhd
Camera
White Balance Initiate White Balance
Zoom Out Zoom out continuously
Zoom In Zoom in continuously
Shutter Automatic Set shutter to automatically control
brightness
Manual Turn off automatic control of brightness
Brighter Increase light level
Darker Decrease light level
Rotate Right Rotate Camera continuously to the right
Left Rotate Camera continuously to the left
Stop Stop Camera rotation
Focus Automatic Set Camera to automatic focus mode
Manual Turn off automatic focus mode
In Focus Camera in
Out Focus Camera out
Stop Stops current rotate/zoom action of the
camera

EN-11
SIDNE Feedback Messages
Notes on Operation
1. Continuous Commands
• The continuous commands on the Berchtold ChromoVision Camera
are Zoom In, Zoom Out, Rotate Left, and Rotate Right. The following
notes relate to the operation of continuous commands:
• While the camera is executing any continuous command initiated by
the SIDNE interface, all commands on the tablet interface and all
commands on the voice interface, except “Stop,” will be disabled.
The camera will not respond to new commands at this point.
When the user says “Stop,” or releases the button on the tablet,
all commands on the voice and tablet interfaces will be enabled.
The camera will now be ready to accept new commands.
• Hold down the tablet button for two seconds to execute any
continuous command on the tablet interface.
SIDNE® Voice
Message Definition
“Connected” Berchtold ChromoVision Camera is powered on and
connected to SIDNE
“Disconnected” Berchtold ChromoVision Camera is connected to SIDNE
and then disconnected or turned off
“White Balance
Complete”
The Berchtold ChromoVision Camera has completed a white
balance
“Focus Automatic/
Manual”
The Berchtold ChromoVision Camera focus is in Automatic/
Manual mode
“Shutter Automatic/
Manual”
The Berchtold ChromoVision Camera shutter is in
Automatic/Manual mode
“Overhead Camera” Added as a prefix to the above messages, when a feedback
message is announced while not in the ChromoVision®
Camera Voice Command menu. added as a prefix to the
"Connected" and "Disconnected" messages

EN-12
2. The White Balance Command
• The Berchtold ChromoVision Camera takes approximately eight
seconds to complete the white balance command. During this period,
all commands on the tablet and voice interfaces, except “Stop,”
are disabled. When the camera completes the white balance action,
all commands on the voice and tablet interfaces will be enabled.
Do not attempt to issue any other commands to the camera while
it is completing the white balance action.
3. Maximum/Minimum Limits
• The Berchtold Camera - SIDNE interface does not provide
information on certain maximum/minimum limits. The SIDNE
interface (voice and tablet) does not provide any indication regarding
the maximum/minimum limits on the following commands:
– Brightness/Darkness
– Focus Out/In
– Rotate Right/Left
– Zoom In/Out
• If any button on the Berchtold Camera front panel is held down for
more than 10 seconds, the device will disconnect. It will reconnect
when the button is released. While any button is held down, no SIDNE
commands will be accepted.

EN-13
Troubleshooting
Problem Possible Solution
No access to device
through SIDNE®
This problem has several possible causes. Please see
below:
EDAM LED stays flashing
red (it should flash green
when functioning
normally)
Contact Stryker Endoscopy or your local Stryker sales
representative for a firmware upgrade.
EDAM LED stays solid
red (it should flash green
when functioning
normally)
The device is not communicating properly with the
SIDNE device EDAM. Ensure that the device is properly
connected to SIDNE.
Attempt the following solutions in order:
• Power off the device.
• Ensure that the device adapter cable is connected to
the EDAM.
• Ensure that the device adapter cable is connected to
the Berchtold ChromoVision Camera control box.
• Power on the device.
EDAM LED stays solid
yellow (it should flash
green when functioning
normally)
SIDNE is not communicating properly with the SIDNE
device EDAM.
Attempt the following fixes in order:
• Power off the device.
• Ensure SIDNE is powered on.
• Ensure that the SIDNE interface cable is connected
to the EDAM.
• Ensure that the SIDNE interface cable is connected
to SIDNE.
• Power on the device.
SIDNE says “Overhead
Camera Disconnected”
• Power off the camera system.
• Ensure that the camera system is properly connected
to SIDNE. (See the “Connecting SIDNE to the
Berchtold ChromoVision® Camera” section of this
manual for further instructions.)
• Power on the camera system.

EN-14
Electromagnetic Compatibility
Like other electrical medical equipment, the SIDNE® Berchtold® ChromoVision
Camera package requires special precautions to ensure electromagnetic
compatibility with other electrical medical devices. To ensure electromagnetic
compatibility (EMC), the SIDNE Berchtold ChromoVision Camera package must
be installed and operated according to the EMC information provided in this
manual.
Note The SIDNE Berchtold ChromoVision Camera package has been
designed and tested to comply with IEC 60601-1-2:2001
requirements for EMC with other devices.
Caution Equipment that employs RF communications may affect the
normal function of the SIDNE Berchtold ChromoVision
Camera package.
Caution This product is considered electronic equipment. It must not
be disposed of as unsorted municipal waste and must be
collected separately. Please contact the manufacturer or other
authorized disposal company to decommission your
equipment.
Warning Do not use cables or accessories other than those provided
with the SIDNE Berchtold ChromoVision Camera package, as
this may result in increased electromagnetic emissions or
decreased immunity to such emissions.
Warning If the SIDNE Berchtold ChromoVision Camera package is
used adjacent to, or stacked with other equipment, observe
and verify normal operation of the SIDNE Berchtold
ChromoVision Camera package in the configuration in
which it will be used prior to using it in a surgical procedure.
Consult the tables below for guidance in placing the SIDNE
Berchtold ChromoVision Camera package.

EN-15
Guidance and Manufacturer’s Declaration: Electromagnetic Emissions
SIDNE® Berchtold® ChromoVision Camera package is intended for use in the electromagnetic
environment specified below. The customer or the user of SIDNE Berchtold ChromoVision
Camera package should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment -
Guidance
RF emissions CISPR 11 Group 1 SIDNE Berchtold ChromoVision Camera
package uses RF energy only for its internal
function; therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions CISPR 11 Class A The SIDNE Berchtold ChromoVision Camera
package is suitable for use in all establishments
other than domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes, provided the
following warning is heeded:
This system is intended for use by health care
professionals only. This system may cause
radio interference or may disrupt the
operation of nearby equipment. It may be
necessary to take mitigation measures, such as
reorienting or relocating the system or
shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
flicker emissions
IEC 61000-3-3
Complies

EN-16
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
SIDNE® Berchtold® ChromoVision Camera package is intended for use in the electromagnetic
environment specified below. The customer or the user of SIDNE Berchtold ChromoVision
Camera package should ensure that it is used in such an environment.
Immunity Test IEC 60601
Te st L e ve l
Compliance
Level
Electromagnetic
Environment:
Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±2,4,6kV contact
±2,4,8kV air
Floors should be
wood, concrete, or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power
supply lines
±1kV for input/
output lines
±2kV line to
ground
±1kV line to line
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC 61000-4-5
±1kV differential
mode
±2kV common
mode
±0.5, 1kV
differential mode
±0.5, 1, 2kV
common mode
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Voltage dips , short
interruption and voltage
variations on power
supply input lines
IEC 61000-4-11
<5% Ut (>95% dip
in Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut) for 25 cycles
<5% Ut (>95% dip
in Ut) for 5 sec.
<5% Ut (>95% dip
in Ut) for 0.5 cycle
40% Ut (60% dip
in Ut) for 5 cycles
70% Ut (30% dip
in Ut) for 25 cycles
<5% Ut (>95% dip
in Ut) for 5 sec.
Mains power quality
should be that of a
typical commercial
or hospital
environment.
If the user of SIDNE
Berchtold
ChromoVision
Camera package
requires continued
operation during
power mains
interruptions, it is
recommended that
SIDNE Berchtold
ChromoVision
Camera package be
powered from an
uninterruptible
power supply or a
battery.

EN-17
Power frequency
(50/60Hz) magnetic field
IEC 61000-4-8
3 A/m N/A Power-frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: Ut is the AC mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
SIDNE Berchtold ChromoVision Camera package is intended for use in the electromagnetic
environment specified below. The customer or the user of SIDNE Berchtold ChromoVision
Camera package should ensure that it is used in such an environment.
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment:
Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
SIDNE Berchtold ChromoVision
Camera package, including its cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Conducted RF 3 Vrms 3 V Recommended Separation Distance
IEC 61000-4-6 150 kHz to
80 MHz
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
SIDNE® Berchtold® ChromoVision Camera package is intended for use in the electromagnetic
environment specified below. The customer or the user of SIDNE Berchtold ChromoVision
Camera package should ensure that it is used in such an environment.
d1.17P=